Safety and Tolerability of Retinoid QLT091001 in Healthy Volunteers

NCT ID: NCT00765427

Last Updated: 2009-03-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2009-03-31

Brief Summary

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Healthy volunteer subjects will receive retinoid QLT091001 once-daily for 7 days for safety observation.

Detailed Description

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Conditions

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Healthy Human Volunteers

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Interventions

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QLT091001

7-day repeated dose

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy subjects with ECG within normal limits and normal blood pressure and resting heart rate

Exclusion Criteria

* Subjects with any clinically important abnormal physical finding at screening.
* Subjects who are actively participating in an experimental therapy study or who have received experimental therapy within 60 days of baseline.
* Female subjects who are either pregnant or lactating.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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QLT Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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QLT Inc.

Principal Investigators

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Victor Lao, MD

Role: PRINCIPAL_INVESTIGATOR

Andrew Strong, Ph.D.

Role: STUDY_DIRECTOR

QLT Inc.

Locations

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Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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RET HV 01

Identifier Type: -

Identifier Source: org_study_id